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NCT03231579 · ClinicalTrials.gov registry record
Chronic Lymphocytic Leukemia Electronic Patient Reported Outcomes Study
A clinical trial, sponsored by Carevive Systems.
- Completed
- Registry status
- 85
- Enrollment target
NCT03231579: Completed study, sponsored by Carevive Systems.
NCT03231579 is a clinical trial that has completed, run by Carevive Systems. The registered enrollment target is 85 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03231579 has completed, sponsored by Carevive Systems.
- COMPLETED
- Registry status
- 85 participants
- Enrollment target
Study Summary
This multi-site study will enroll approximately 100 CLL patients across 5 cancer institutions. The aim of the project is to ensure hematology care teams that are participating in new value-based reimbursement models have an accurate understanding of the evidence and roles of new therapies for CLL and best practice supportive care protocols to proactively assess, monitor, and manage symptoms to promote successful clinical outcomes. Hematology teams at seven health systems across the U.S. will be given online clinical training on the latest evidence for treatment planning in CLL along with best supportive care practices for patients on novel CLL treatments, prior to using Carevive's patient engagement software. Once training is complete, the Carevive software will be employed in the clinic whereby CLL patients will use the Carevive patient portal to report any symptoms at and in between clinic visits. Patients will be given a user name and password to a web-based portal for 24/7 reporting of symptoms experienced. Patient-reported and clinical data will be processed by the Carevive rules engine technology to generate evidence-based supportive care plans providing patients with direction regarding self-management strategies, care coordination for relevant cancer center services, and direction on when to go to the emergency department (ED) or call their hematologist based on their institution's protocol. For patients who require ongoing and routine monitoring, such supportive care recommendations will be included in supportive care plans generated at the clinic visit. On the visits subsequent to the delivery of the care plan, patients will report on the perceived effectiveness of the intervention (or barriers to non-adherence to the intervention). Patients and clinicians will assess symptom severity at each visit for a 16-week period and both data sets will be stored and analyzed for research purposes.
Primary Outcome
Patients will be asked to rate how acceptable, effective, and usable the web-based technology was using a 5-item system usability measure. The data will then be analyzed in order to describe the patient perceptions of the intervention
Interventions
- BEHAVIORAL Carevive CPS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2017-07-21 |
| Est. Completion | 2019-03-31 |
What the finished NCT03231579 record still lists
NCT03231579 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 85 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Carevive CPS is the first listed.
NCT03231579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03231579 about?
NCT03231579 is a clinical study titled "Chronic Lymphocytic Leukemia Electronic Patient Reported Outcomes Study". This multi-site study will enroll approximately 100 CLL patients across 5 cancer institutions. The aim of the project is to ensure hematology care teams that are participating in new value-based reimbursement models have an accurate understanding of the evidence and roles of new therapies for CLL an...
What is the current status of trial NCT03231579?
This trial is currently completed. The enrollment target is 85 participants. The study started on 2017-07-21. Estimated completion is 2019-03-31.
What interventions are being tested in trial NCT03231579?
The interventions under investigation include: Carevive CPS (BEHAVIORAL).
Who is sponsoring clinical trial NCT03231579?
This trial is sponsored by Carevive Systems, which has 10 total clinical trials registered on ClinicalTrials.gov.
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